Phase 3 randomized study of adjuvant anastrozole (A), exemestane (E), or letrozole (L) with or without tamoxifen (T) in postmenopausal women with hormone-responsive (HR) breast cancer: The FATA-GIM3 trial.

515 Background: Uncertainty still exists regarding the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors (AI) and no trial has ever compared all the three AI. Methods: FATA-GIM3 is a multicenter, open label, 2x3 factorial phase 3 randomized study of adjuvant A, E and L upfront (UP - for 5 years) or sequentially (SEQ - for 3 years after 2 years of T) in postmenopausal HR breast cancer pts. Two comparisons were planned: UP vs SEQ and A vs E vs L. DFS (including local or distant relapse, second breast or non-breast cancer, DCIS and death, whichever came first) was the primary end-point; 2% at 5 yrs (corresponding to a HR of 0.79) was defined as the minimum diff…

Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial

Purpose : To compare mitomycin C plus vindesine plus etoposide (MEV) vs. mitomycin C plus vindesine plus cisplatin (MVP) in the treatment of stage IV non-small-cell lung cancer. Patients and methods : 204 patients were entered in a phase III multicentre randomised trial from June 1990 to December 1994 and stratified according to the ECOG performance status (0-1 vs. 2). MVP was given in the following dosages : mitomycin C 8 mg/m 2 + vindesine 3 mg/m 2 + cisplatin 100 mg/m 2 i.v. day 1 and vindesine 3 mg/m 2 i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages : mitomycin C 8 mg/m 2 + vindesine 3 mg/m 2 i.v. day I and etoposide 100 mg/m 2 i.v. days 1 to 3 with…

Lung cancer: does age affect treatment strategy?

Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer. Preliminary activity results of the MITO-2 phase III trial

<i>Background:</i> Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis. <i>Patients and Methods:</i> Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m<sup>2</sup> or PLD 30 mg/m<sup>2</sup> every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single…

SARS-CoV-2 vaccination modelling for safe surgery to save lives: data from an international prospective cohort study

Abstract Background Preoperative SARS-CoV-2 vaccination could support safer elective surgery. Vaccine numbers are limited so this study aimed to inform their prioritization by modelling. Methods The primary outcome was the number needed to vaccinate (NNV) to prevent one COVID-19-related death in 1 year. NNVs were based on postoperative SARS-CoV-2 rates and mortality in an international cohort study (surgical patients), and community SARS-CoV-2 incidence and case fatality data (general population). NNV estimates were stratified by age (18–49, 50–69, 70 or more years) and type of surgery. Best- and worst-case scenarios were used to describe uncertainty. Results NNVs were more favourable in su…

Emergency hernia repair in the elderly: multivariate analysis of morbidity and mortality from an Italian registry

Abstract Purpose The incidence of inguinal hernia is higher in elderly because of aging-related diseases like prostatism, bronchitis, collagen laxity. A conservative management is common in elderly to reduce surgery-related risks, however watchful waiting can expose to obstruction and strangulation. The aim of the present study was to assess the impact of emergency surgery in a large series of elderly with complicated groin hernia and to identify the independent risk factors for postoperative morbidity and mortality. The predictive performance of prognostic risk scores has been also assessed. Methods This is a prospective observational study carried out between January 2017 and June 2018 in…

Frailty and emergency surgery in the elderly: protocol of a prospective, multicenter study in Italy for evaluating perioperative outcome (The FRAILESEL Study)

Improvements in living conditions and progress in medical management have resulted in better quality of life and longer life expectancy. Therefore, the number of older people undergoing surgery is increasing. Frailty is often described as a syndrome in aged patients where there is augmented vulnerability due to progressive loss of functional reserves. Studies suggest that frailty predisposes elderly to worsening outcome after surgery. Since emergency surgery is associated with higher mortality rates, it is paramount to have an accurate stratification of surgical risk in such patients. The aim of our study is to characterize the clinicopathological findings, management, and short-term outcom…

Surgeons' fear of getting infected by COVID19: A global survey

During the last three months, COVID- 19 pandemic had led to a serious backlog of operations globally, and plans for restarting operation are imperative. Recommendations for surgical activities were studied, aiming to protect the surgical staff from being infected. In the meantime, it is also important to give attention to the surgeon’s personal feeling during work. We conducted a survey to investigate global surgi- cal practices during the COVID-19 pandemic, and the surgeon’s personal feeling was also investigated in the sur- vey. In this special letter, we performed multivariate analysis to explore factors that associated with surgeon’s fear of getting infected by COVID-19.

COVID-19 infection in cancer patients: what has been the contribution of Associazione Italiana Oncologia Medica (AIOM) to oncological care since the beginning of the first pandemic wave?

High mortality rates in elderly patients or in those with underlying chronic illnesses and/or a compromised immune system is a peculiar feature of COVID-19 infection. The possible coexistence of a cancer and COVID-19 infection in the same individual prompted concerns regarding their synergistic effect on prognosis. In order to balance patients’ needs with the risks related to the infection, the question oncologists have asked from the beginning of the first wave of the pandemic has been: ‘how can we deal with COVID-19 infection in cancer patients?’ In pursuing its mission, the Associazione Italiana Oncologia Medica (AIOM) has made every possible effort to support cancer patients, health car…

Impact of asymptomatic COVID-19 patients in global surgical practice during the COVID-19 pandemic

The rapid spread of COVID-19 has changed the global surgical care. Patients infected with COVID-19 may present without typical symptoms, and such asymptomatic patients may potentially trigger in-hospital outbreaks by transmitting the disease to health care providers and other hospitalized patients. Further, asymptomatic COVID-19 patients have worse postop- erative outcomes with an unexpectedly high morbidity and mortality, reaching 20⋅5 per cent deaths. However, we do not have objective global data on this issue. In an attempt to clarify the current global surgical practice under the COVID-19 pandemic particularly focusing on the preoperative screening of asymptomatic COVID-19 patients, we …

A Multicenter Large Retrospective Database on the Personalization of Stereotactic Ablative Radiotherapy for Lung Metastases From Colon-Rectal Cancer: The LaIT-SABR Study

PURPOSE/OBJECTIVE(S): stereotactic ablative radiotherapy (SABR) has been shown to increase survival rates in oligometastatic disease (OMD), but local control of colorectal metastases still remains poor. We aimed to identify potential predictive factors of SBRT response through a multicenter large retrospective database and to investigate how lung SBRT can impact on the progression to the polymetastatic disease (PMD). MATERIALS/METHODS: the study involved 22 centers, and was approved by the Ethical Committee (Prot. Negrar 2019-ZT). 1023 lung metastases treated with SBRT in 622 patients were reported. The median BED was 105 Gy10. Lesion diameter GTV, PTV volume, dose, fractionations, and site…

Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer

Pain is a highly distressing symptom for patients with advanced cancer. WHO analgesic ladder is widely accepted as a guideline for its treatment. Our aim was to describe pain prevalence among patients diagnosed with advanced non-small-cell lung cancer (NSCLC), impact of pain on quality of life (QoL) and adequacy of pain management. Data of 1021 Italian patients enrolled in three randomised trials of chemotherapy for NSCLC were pooled. QoL was assessed by EORTC QLQ-C30 and LC-13. Analgesic consumption during the 3 weeks following QoL assessment was recorded. Adequacy of pain management was evaluated by the Pain Management Index (PMI). Some pain was reported by 74% of patients (42% mild, 24% …

Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study

The aims of this multicentre, randomised phase III trial were to evaluate: (1) the role of levamisol (LEV); and (2) the role of folinic acid (FA), added to 5-fluorouracil (5FU) in the adjuvant treatment of colorectal cancer. Patients with histologically proven, radically resected stage II or III colon or rectal cancer were eligible. The study had a 2x2 factorial design with four treatment arms: (a) 5FU alone, (b) 5FU+LEV, (c) 5FU+FA, (d) 5FU+LEV+FA, and two planned comparisons, testing the role of LEV and of FA, respectively. From March 1991, to September 1998, 1327 patients were randomised. None of the two comparisons resulted in a significant disease-free (DFS) or overall (OAS) survival a…